Topwide Surgical Face Mask

K210102 · Topwide (Hubei) Medical Products Manufacturer · FXX · Dec 17, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210102
• Device Name: Topwide Surgical Face Mask
• Applicant: Topwide (Hubei) Medical Products Manufacturer
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The TOPWIDE surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.

Device Story

Flat-pleated surgical face mask; consists of three layers: outer spunbond polypropylene, middle melt-blown polypropylene filter, inner spunbond polypropylene; features malleable plastic-coated steel nosepiece and polyester/spandex ear loops. Used in clinical settings by healthcare personnel and patients to provide physical barrier against microorganisms, body fluids, and particulates. Device provides Level II fluid resistance per ASTM F2100. User secures mask via ear loops and adjusts nosepiece for fit. Single-use, non-sterile, disposable.

Clinical Evidence

Bench testing only. Performance verified against ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration efficiency ≥99.78%), ASTM F2101 (bacterial filtration efficiency ≥98%), 16 CFR 1610 (flammability Class 1), and ASTM F2100 (differential pressure <2.94 mmH2O/cm2). Biocompatibility testing per ISO 10993-5 and ISO 10993-10 confirmed no cytotoxicity, irritation, or sensitization.

Technological Characteristics

Three-layer construction: spunbond polypropylene (outer/inner), melt-blown polypropylene (filter). Malleable plastic-coated steel nosepiece. Polyester/spandex ear loops. Dimensions: 17.5 cm x 9.5 cm. Meets ASTM F2100 Level II fluid resistance. Non-sterile. No natural rubber latex.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings. Single-use, non-sterile.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• Single-Use Surgical Mask with Ear Loop (K201691)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 17, 2021

Topwide Medical Products Manufacturer % Jimmy Wu Associate Lee and Xiao 2600 Mission Street, Suite 206 San Marino, California 91108

Re: K210102

Trade/Device Name: Topwide Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: General Hospital Regulatory Class: Class II Product Code: FXX Dated: October 30, 2021 Received: November 3, 2021

Dear Jimmy Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K210102

Device Name TOPWIDE SURGICAL FACE MASK

### Indications for Use (Describe)

The TOPWIDE surgical face mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the posure to blood and body fluids. This device is non-sterile and for single use only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

# 510(k) Summary K210102

| 1. Type of 510(k) submission: | Traditional | Submitted on: | 12/13/2021 |
|-------------------------------|--------------------------------------------------------------------|---------------|-----------------|
| 2. Device Type: | Mask, Surgical | | |
| 3. 510(k) Submitter/Owner: | | | |
| Name: | Topwide (Hubei) Medical Products Manufacturer | | |
| Address: | 19 Xianhong Road, Xin Li Ren Kou<br>Xiantao, Hubei 433012<br>CHINA | | |
| Phone: | 86-728-2714000 | Fax: | 86-728-2712999 |
| Contact: | Jimmy Wu | Email: | [e-mail] |
| 4. Device: | | | |
| Common Name: | Surgical Face Mask | | |
| Trade Name: | Topwide Surgical Face Mask | | |

CFR Section: Product Classification: Classification Panel: Product Code:

21 CFR 878.4040 Class II General Hospital FXX

- 5. Basis for the Submission: New Device
- Predicate Device: Single-Use Surgical Mask with Ear Loop (K201691) 6.

#### 7. Indication For Use:

The TOPWIDE surqical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.

#### 8. Device Description:

The Topwide surgical face mask is with white color outer laver and white inner layer. Subject device is a Flat Pleated type mask, utilizing ear-loop way for wearing, and it has a nose piece design for fitting the facemask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner laver (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask has Level II fluid resistance under ASTM F2100. The mask is a single use, provided non

{4}------------------------------------------------

sterile.

This product contains no components made with natural rubber latex.

| | Subject Device - Topwide | Predicate Device - Single-Use | |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|------------|
| | Surgical Face Mask | Surgical Mask with Ear Loop | |
| Device | (K210102) | (K201691) | Comparison |
| | The TOPWIDE surgical face mask | The Single-Use Surgical Mask | |
| | is intended to be worn to | with Ear Loop is intended to be | |
| | protect both patient and | worn to protect both the | |
| | healthcare personnel from | patient and healthcare | |
| | transfer of microorganisms, | personnel from the transfer of | |
| | body fluids and particulate | microorganisms, body fluids, | |
| | material. The TOPWIDE surgical | and particulate material. The | |
| Intended Use | intended for use in infection | Single-Use Surgical Mask with | Same |
| | control practices to reduce the | Ear Loop intended for use in | |
| | potential exposure to blood and | infection control practices to | |
| | body fluids. This device is non- | reduce the potential exposure | |
| | sterile and for single use only. | to blood and body fluids. This is | |
| | | a single-use, disposable | |
| | | device(s), provided non-sterile. | |
| | | Model: M and L, blue color, and | |
| | | Level | |
| | | 2 barrier level as ASTM F2100. | |
| Design feature | | | |
| | Spun-bond polypropylene | | |
| Outer layer | | Spun-bond polypropylene | |
| | Melt blown | | |
| Middle layer | polypropylene | Melt blown non-woven fabric | SAME |
| | Spun-bond polypropylene | | |
| Inner layer | | Spun-bond polypropylene | |
| | Wire, malleable nosepiece, | | |
| | plastic- | Wire, malleable aluminum | DIFFERENT |
| Nose piece | coated steel | nosepiece | |
| | Polyester and spandex | | |
| Ear Loops | materials | Polyester | SAME |
| | | | |
| | | | DIFFERENT |
| Color | White outer layer | Blue | |
| Mask style | Flat pleated, Ear- | Flat pleated, Ear-Loop | SAME |
| | Loop<br>Length: 17.5 cm ± 0.5 cm, Width: | | |
| Size | 9.5 cm ± | Large: Length - 18 cm ± 1 cm, Width | DIFFERENT |
| | 0.5 cm | 9 cm<br>± 1 cm | |
| Single Use | ત્વની દિવેલા તાલુકામાં આવેલું એક ગામ છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગના અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને | Yes | |
| OTC Use | yes | Yes | SAME |
| Sterile | Non-Sterile | Non-Sterile | |

#### 9. Technological Characteristic Comparison

{5}------------------------------------------------

| Performance | | | |
|----------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------|
| ASTM F2100<br>Level | II | II | SAME |
| Fluid resistance<br>(ASTM F1862) | 32 out of 32 pass at<br>16Kpa (120 mmHg) | 31 out of 32 pass at 120 mmHg | |
| Particulate<br>Filtration (ASTM<br>F2299) | $\ge$ 99.78% | > 99% | SIMILAR |
| Bacterial Filtration<br>(ASTM F2101) | $\ge$ 98% | > 99% | |
| Differential<br>Pressure (Delta-P)<br>(ASTM F2100) | <28.8 pa/cm2<br>(2.94 mmH2O/cm2) | < 5.0 mmH2O/cm2 | |
| Biocompatibility<br>ISO10993 | Irritation (ISO 10993-10),<br>Sensitization (ISO 10993-10),<br>Cytotoxicity (ISO 10993-5) | Irritation (ISO 10993-10),<br>Sensitization (ISO 10993-10),<br>Cytotoxicity (ISO 10993-5) | SAME |
| Flammability | Class 1 | Class 1 | |

{6}------------------------------------------------

#### 10. Summary of Non-Clinical Test

| Following performance data has been provided from 3 nonconsecutive lots to | |
|--------------------------------------------------------------------------------|--|
| demonstrate that the subject device meet the acceptance criteria the standard. | |
| | |

| Test Methodology,<br>Standard | Purpose | Acceptance Criteria | Results |
|-------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|
| ASTM F1862 | Resistance to penetration<br>by synthetic blood | 120 mm Hg | 120 mm Hg |
| ASTM F2299 | Particulate filtration<br>efficiency | ≥ 98% | >99% |
| ASTM F2101 | Bacterial filtration | ≥ 98% | ≥ 98% |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
| ASTM F2100 | Differential Pressure<br>(Delta-P) | < 6.0 mm H2O/cm2 | 2.94<br>mmH2O/cm2 |
| ISO 10993-5, ISO 10993-10 | Biocompatibility | Not cytotoxic, irritating<br>or sensitizing under the<br>conditions of the<br>studies | PASSED |

#### Conclusion 11.

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.